Randomized Trial to Test the "Coordinated Care for Health Promotion and Activities in Parkinson's Disease" Intervention in the VA



Status:Completed
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:3/10/2019
Start Date:July 9, 2012
End Date:April 30, 2017

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Improving Quality of Care in Parkinson's Disease: A Randomized Controlled Trial

Health care benefits and services are received through the Veterans Health Administration
(VHA), a component of the United States Department of Veterans Affairs. Over 40,000 Veterans
across the Veterans Health Administration are diagnosed with Parkinson's disease (PD), a
chronic condition that affects motor function as well as cognition, mood, sleep, and
autonomic function. There are not enough subspecialists to manage every Veteran with
Parkinson's disease. However, a care model of nurse care managers as catalysts and advocates
using needs assessments, evidence-based protocols, and VHA and community access coordination
mechanisms to optimize Parkinson's disease care may improve quality of Parkinson's disease
care and patient-centered outcomes. If efficacious, this model may be practical to
disseminate via an existing VHA national consortium network for Parkinson's disease.

Objectives are (1) to implement then analyze via a randomized controlled trial whether a
nurse-led, coordinated care management intervention, Care Coordination for Health Promotion
and Activities in Parkinson's Disease (CHAPS), compared to usual care will improve adherence
to evidence-based practice guidelines and improve health outcomes in Veterans with
Parkinson's disease in a region of the southwest United States, and (2) to analyze extent of
implementation of the CHAPS intervention and its costs to determine how the intervention can
be made sustainable and disseminated throughout Veterans Affairs Medical Centers if
efficacious.

In a 5-year randomized controlled trial, we enrolled 345 Veterans with PD that were then
randomized in a 1:1 ratio to receive up to 24 months of a PD care management program, "Care
Coordination for Health Promotion and Activities in Parkinson's Disease" (CHAPS), or continue
with usual care. Eligible participants across 5 sites of the Southwest Parkinson's Disease
Research, Education and Clinical Center (SW PADRECC): Greater Los Angeles, Las Vegas, Loma
Linda, Long Beach and San Diego VISN 22 (VA Desert Pacific Healthcare Network) facilities
were identified through administrative data and vetted by physicians. The multi-faceted
nurse-led intervention, CHAPS, incorporated PD quality improvement (QI) tools to enhance
proactive Veteran-centered care delivery. PDQI tools included: (1) a structured telephone
assessment administered by a nurse care manager (NCM) to proactively identify medical
problems and unmet needs; (2) problem-specific evidence-based interventions organized into
treatment plans including follow-up/monitoring protocols with VA and community linkages; (3)
the Siebens Domain Management ModelTM, a structural approach to improve collection and
organization of health information and enrich communication among providers; (4) Siebens
Health Care Notebooks prepared with Veteran self-management materials; (5) a Microsoft Access
care management database, containing the CHAPS Assessment and algorithms for problem
identification based on Veteran data; and (6) decision-support meetings of NCMs with movement
disorder specialists. Research interviewers administer a structured telephone survey at
baseline, 6, 12, 18, and 24 months. Participants were provided $25 per survey. Medical
records were abstracted.

Ongoing analyses (1) measure PD quality indicator adherence, health outcomes, and health
service utilization; (2) evaluate qualitative and quantitative data to summarize the extent
of intervention implementation and barriers and facilitators to potential dissemination; and
(3) examine costs of CHAPS care and cost offset between randomization arms to provide new
knowledge to aid in future dissemination of the CHAPS Program in a "National Rollout"
according to the VA Quality Enhancement Research Initiative QUERI process.

Inclusion Criteria:

- Veteran of the United States of America

- Receiving health care at one of five Veterans Health Administration medical centers in
the southwest United States: Greater Los Angeles, Loma Linda, Long Beach, or San
Diego, California, or Las Vegas, Nevada.

- Diagnosis of Parkinson's disease (PD)

- At least two ICD-9 diagnostic codes for PD (332.0) in the administrative data from
October 1, 2010 - to present date or until recruitment target is met

- At least 18 years of age

- Must demonstrate capacity to provide consent for study participation.

Exclusion Criteria:

- Any Veteran who is a study subject in the Deep Brain Stimulation (DBS) VA cooperative
study as these subjects are not to enroll in any other study per DBS study protocol.
We found this trial at
5
sites
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West Los Angeles, CA
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Las Vegas, NV
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Loma Linda, CA
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Long Beach, CA
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San Diego, California 92161
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San Diego, CA
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